MARACA International invited to attend the RAPS Netherlands Chapter meeting

Dr. Luc Van Hove from MARACA International has been invited to participate in the RAPS Netherlands Chapter meeting, which can only be attended by special invitation only.
Taking place on 9 February 2018 in Arnhem, MARACA International will exchange ideas on the implementation of the new medical device regulations (MDR) and in-vitro diagnostic medical device regulation (IVDR).
In addition, the implementation acts and guidance will be reviewed. As well as the status of the notified body accreditations and transition will be discussed.
Other items of discussion include the future of MEDDEVs and common specifications. How to develop clinical evaluations for products under the MDR and IVDR.  Finally, the post-market surveillance and risk management requirements will be discussed under the new regulations.
There will be a lot of questions and MARACA International will be the first to understand the best answers.

Amstelveen Companion Diognostics RAPS NL Meeting

Companion Diagnostics IVDR implementation

Luc Van Hove, Founder of MARACA International and Principal Consultant is presenting on Companion Diagnostics IVDR regulation implementation from an IVD Company perspective at the RAPS Netherlands Chapter Meeting, 24 November in Amstelveen, The Netherlands.  Learnings: Understanding the difference between Companion diagnostic devices and Complementary diagnostic devices. The implementation steps of the IVDR for these products. What pathway to follow.

See also e-learning training on Companion Diagnostics.

MARACA International is a consulting company providing service excellence in Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies.

Medica 2017 exhibition

Medica 2017 Trade Fair

MARACA International participates at the Medica 2017 Trade Fair, 13-16 November, in Dusseldorf, Germany. When you want to learn more about the consulting services of MARACA International or want to meet Dr. Luc Van Hove, its CEO, contact lucvanhove@maracainternational.com or call 32476960153 to set up an appointment.

MARACA International provides consulting excellence for Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies. The services include setting up quality systems, risk management, organization of clinical studies and product registrations in the EU and the USA.

see Medica 2017 video on spotlight.

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RAPS Regulatory Convergence

MARACA International will be at the RAPS Regulatory Convergence, National Harbor, Washington DC Waterfront, 9-12 September, 2017.

You can meet Dr. Van Hove at the convention by contacting him at maracainternational.com

Pilot for Software

FDA launched pilot for Software as a Medical Device (SaMD) Precertification program

FDA launched on August 1st a new pilot for Software as a Medical Device (SaMD) Precertification program. US software manufacturers and software manufacturers from abroad can apply for participation. FDA intends to select 9 companies to learn from their best practices of software development. Other software companies will be allowed to provide continuous input. FDA and these 9 companies (large, small, traditional, new entrant, best-in-class, low and high risk) will develop Key Performance Indicators (KPIs) to monitor whether a software manufacturer has a culture of quality and of organizational excellence.

This company culture of quality and organizational excellence needs to provide a safe patient experience; deliver the highest product quality; being clinically responsible; being cybersecurity responsible; and being proactive instead of reactive. By January 2018 FDA will report their findings. This new concept should allow faster market authorization for new innovative SaMDs through a new route of software manufacturer precertification. This precertification would result into a streamlined premarket review and a faster commercial distribution and real-world use. The software manufacturer would collect real-world data to further improve their SaMD.

For MARACA International support with your US authorization of your SaMD contact us  for a discussion and proposal.

Brussels Workshop

MARACA International was at the RAPS EU MDR/IVDR Brussels Workshop 4–5 July 2017.

Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation (MDR) and the new In vitro Diagnostic Device Regulation (IVDR).

MedTech Summit Meeting

MARACA International was at the MedTech Summit Meeting in Amsterdam, The Netherlands, on 19-23 June 2017.

Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation and the new In vitro Diagnostic Device Regulation.

Companion Diagnostics

Dr. Van Hove presented on Companion Diagnostics at the DIA 29th Annual Euromeeting , 29-31 March 2017 in Glasgow,  UK

Dr. Van Hove was asked to share his experience with setting up companion diagnostics projects with pharmaceutical companies and in vitro diagnostic device manufacturer as partners. He highlighted the opportunities and the difficulties with such partnerships. Dr. Van Hove summarized how a successful companion diagnostics partnership could be setup and lead to the successful registrations of the drug and the companion diagnostic device.

European General Data Protection Regulation (GDPR)

On 4 May 2016, the official text of the GDPR Regulation has been published in the EU Official Journal. While the Regulation entered into force on 24 May 2016, it shall apply from 25 May 2018.

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

The Regulation is an essential step to strengthen citizens’ fundamental rights in the digital age and facilitate business by simplifying rules for companies in the Digital Single Market. Violations can cost a company up to 4% of worldwide revenue.  More details can be found here.